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临床试验/CTRI/2025/01/079154
CTRI/2025/01/079154尚未招募不适用

Effectiveness Of Silver Diamine Fluoride And Fluoride Varnish In Preventing Dental Caries In Primary Molars Among The Children Of 3-6 Year In Visnagar: A Randomised Controlled Trial

Dr Dimpal Parmar1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2025年2月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
84
试验地点
1
主要终点
This can prevent the progression of caries lesions to more advanced stages, reducing the need for invasive and costly treatments in the future.

研究概览

简要总结

This randomized controlled trial with split mouth study design will include 84 children of age group 3-6 years having bilateral caries free deciduous molars. In each patient, teeth will be randomly divided in two groups in which SDF and Fluoride varnish application will be done. Questionnaire regarding demographic data, dietary habit, oral hygiene habit and socioeconomic status will be administered to the parents. Bitewing radiograph will be taken as a baseline record. Clinical examination will be done using ICDAS Criteria and Bitewing radiograph will be taken as a baseline record. SDF and Fluoride Varnish application - with the help of Y shaped dental floss holder with floss and micro brush (Group A and B). Biannual application - with the follow up of 6, 12 and 18-months using bitewing radiograph. ICCMSâ„¢ (International Caries Classification and Management System) method will be used for radiographic assessment. Data will be entered in Microsoft excel and analyzed.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
3.00 Year(s) 至 6.00 Year(s)(—)
性别
All

入选标准

  • Children aged between 3-6 years Children with bilateral caries-free deciduous molars Children whose parent gives the written consent.

排除标准

  • Children with the evidence of caries in deciduous molars Children with special health care needs Children with any systemic disease or premature birth Children having developmental anomalies in the shape and size of teeth.

结局指标

主要结局

This can prevent the progression of caries lesions to more advanced stages, reducing the need for invasive and costly treatments in the future.

时间窗: 1.8 Years

次要结局

  • Development of evidence-based preventive care practices in pediatric dentistry.(Facilitate early intervention strategies for managing dental caries in young children.)

研究者

发起方
Dr Dimpal Parmar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Dimpal Parmar

Narsinhbhai Patel Dental College and Hospital

研究点 (1)

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